Epidural AnesthesiaPhase 1/2PCEANCT03195309
A Comparison of Different Concentration Ropivacaine for Patient-controlled Epidural Analgesia
A Phase 1/2 study testing Ropivacaine and Fentanyl in people with Epidural Anesthesia and Cesarean Section, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
To compare the postoperative analgesic effect and the intensity of motor block in different concentration ropivacaine plus fentanyl when used epidurally with a patient-controlled analgesia device after Cesarean delivery. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Epidural Anesthesia, Cesarean Section
- What is being tested?
- Ropivacaine and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jan 2017to Jun 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female undergoing elective Cesarean delivery and receive patient-controlled epidural analgesia
Who cannot join
- With the comorbidity of chronic heart, lung, liver and renal disease, chronic alcoholism, allergy to ropivacaine, poor epidural function and combine other anesthesia method
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Different Concentration Ropivacaine Combination With Fentanyl for Patient-controlled Epidural Analgesia After Cesarean Delivery
To compare the postoperative analgesic effect and the intensity of motor block in different concentration ropivacaine plus fentanyl when used epidurally with a patient-controlled analgesia device after Cesarean delivery.
Read the detailed description
- Written informed consent must be obtained before any study specific procedures are undertaken.
- All patients were received epidural anesthesia with 2% Lidocaine and patient-controlled epidural analgesia (PCEA) for post- operative pain control. PCEA randomly allocated into three groups. Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl, Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl, and Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl. Dermographic data, dosage of PCEA during first 48 hours post-operation，NRS scores, patient satisfaction and the intensity of motor block will be recorded and analyzed.
- Conditions
- Epidural Anesthesia, Cesarean Section
- Being tested
- Ropivacaine, Fentanyl
- Keywords
- Cesarean Delivery, Ropivacaine, Fentanyl, Patient-controlled Epidural Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Ropica
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
FentanylDrug
Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl Receives: Drug: Ropivacaine; Drug: Fentanyl |
| Group B | Active comparator | Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl Receives: Drug: Ropivacaine; Drug: Fentanyl |
| Group C | Active comparator | Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl Receives: Drug: Ropivacaine; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Scores on the numeric rating scale
The investigators use numeric rating scale(0~10) for pain severity measurement, 0 for no pain, 10 is the most severe pain
Measured: The investigators measured numeric score changing at 5 different timing. The first is when arrival post-operative care unit, the second is when arrival post-operative care unit for 2 hours. And then 6,24,48 hours after operation.
Secondary outcomes (1)
Change From Baseline in Patient satisfaction scale
Patient satisfaction scale (1~4), 1 for very satisfied, 2 for satisfied, 3 for fair, and 4 for unsatisfied
Measured: The investigators measured numeric score changing at 5 different timing. The first is when arrival post-operative care unit, the second is when arrival post-operative care unit for 2 hours. And then 6,24,48 hours after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start20 Jan 2017
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnesthesiaStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients were received epidural anesthesia with 2% Lidocaine and patient-controlled epidural analgesia (PCEA) for post- operative pain control. PCEA randomly allocated into three groups. Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl, Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl, and Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl. Dermographic data, dosage of PCEA during first 48 hours post-operation，NRS scores, patient satisfaction and the intensity of motor block will be recorded and analyzed.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Fang Huang, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195309
- Sponsor's protocol ID
- KMUHIRB-F(1)-20160019
- Acronym
- PCEA
- Status last verified
- Apr 2017
- First submitted
- 18 Apr 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Different Concentration Ropivacaine Combination With Fentanyl for Patient-controlled Epidural Analgesia After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03195309
- Acronym / sponsor ID
- PCEA / KMUHIRB-F(1)-20160019
- Conditions
- Epidural Anesthesia, Cesarean Section
- Keywords
- Cesarean Delivery, Ropivacaine, Fentanyl, Patient-controlled Epidural Analgesia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the postoperative analgesic effect and the intensity of motor block in different concentration ropivacaine plus fentanyl when used epidurally with a patient-controlled analgesia device after Cesarean delivery.
Detailed description
- Written informed consent must be obtained before any study specific procedures are undertaken.
- All patients were received epidural anesthesia with 2% Lidocaine and patient-controlled epidural analgesia (PCEA) for post- operative pain control. PCEA randomly allocated into three groups. Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl, Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl, and Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl. Dermographic data, dosage of PCEA during first 48 hours post-operation，NRS scores, patient satisfaction and the intensity of motor block will be recorded and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- All patients were received epidural anesthesia with 2% Lidocaine and patient-controlled epidural analgesia (PCEA) for post- operative pain control. PCEA randomly allocated into three groups. Group A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl, Group B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl, and Group C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl. Dermographic data, dosage of PCEA during first 48 hours post-operation，NRS scores, patient satisfaction and the intensity of motor block will be recorded and analyzed.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Ropivacaine, Drug: FentanylGroup A patients received 0.08% ropivacaine plus 4 mcg /mL fentanyl |
| Group B | Active comparator | Drug: Ropivacaine, Drug: FentanylGroup B patients received 0.08% ropivacaine plus 2mcg /mL fentanyl |
| Group C | Active comparator | Drug: Ropivacaine, Drug: FentanylGroup C patients received 0.16 % ropivacaine plus 2 mcg /mL fentanyl |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female undergoing elective Cesarean delivery and receive patient-controlled epidural analgesia
Key exclusion criteria (1 listed)
- With the comorbidity of chronic heart, lung, liver and renal disease, chronic alcoholism, allergy to ropivacaine, poor epidural function and combine other anesthesia method
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: RopicaCompare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control. | Drug | Group A, Group B, Group C |
| FentanylCompare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control. | Drug | Group A, Group B, Group C |
Primary outcome
Change From Baseline in Pain Scores on the numeric rating scale
Time frame: The investigators measured numeric score changing at 5 different timing. The first is when arrival post-operative care unit, the second is when arrival post-operative care unit for 2 hours. And then 6,24,48 hours after operation.
The investigators use numeric rating scale(0~10) for pain severity measurement, 0 for no pain, 10 is the most severe pain
1 secondary outcome
Change From Baseline in Patient satisfaction scale
Time frame: The investigators measured numeric score changing at 5 different timing. The first is when arrival post-operative care unit, the second is when arrival post-operative care unit for 2 hours. And then 6,24,48 hours after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Fang Huang principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ropivacaine and Fentanyl in people with Epidural Anesthesia and Cesarean Section, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pain Scores on the numeric rating scale (time frame: The investigators measured numeric score changing at 5 different timing. The first is when arrival post-operative care unit, the second is when arrival post-operative care unit for 2 hours. And then 6,24,48 hours after operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.